The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) inspected the trainer and the iabp unit.The problem was found to be from the connection of the iabp.There was a sheet metal stuck inside the trainer connector (blue).To address the issue the fse replaced the front end board and performed all functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.
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